| CTRI Number |
CTRI/2025/07/090348 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Audio-video ICF] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Using a Digital Tool to Make Research Consent Easier for Cancer Patients
|
|
Scientific Title of Study
|
Development and pilot evaluation of an audio-visual application to enhance the understanding of the informed consent process among research participants at a tertiary-referral cancer center. |
| Trial Acronym |
AVICARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Abhidnya V Desai |
| Designation |
Scientific Officer D and TRAC Coordinator |
| Affiliation |
Tata Memorial Hospital Mumbai India |
| Address |
Tata Memorial Hospital, Institutional Review Board Dept, Main Building 372, Dr E Borges, Marg Parel 400012 Mumbai India
Institutional Review Board Dept, Main Building 372, Dr E Borges, Marg Parel 400012 Mumbai India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833348059 |
| Fax |
|
| Email |
avdesai06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajiv Sarin |
| Designation |
Professor Radiation Oncology, Incharge Cancer Genetics Clinic |
| Affiliation |
Tata Memorial Hospital Mumbai India |
| Address |
Tata Memorial Hospital, Dr E Borges Marg Parel 400012 Mumbai India
Dr E Borges Marg Parel 400012 Mumbai India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820313789 |
| Fax |
|
| Email |
drrajivsarin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Abhidnya V Desai |
| Designation |
Scientific Officer D and TRAC Coordinator |
| Affiliation |
Tata Memorial Hospital Mumbai India |
| Address |
Tata Memorial Hospital Institutional Review Board Dept, Main Building 372, Dr E Borges, Marg Parel 400012 Mumbai India
Institutional Review Board Dept, Main Building 372, Dr E Borges, Marg Parel 400012 Mumbai India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833348059 |
| Fax |
|
| Email |
avdesai06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biotechnology Industry Research Assistance Council (BIRAC)
5th Floor, NSIC Business Park, NSIC Bhawan,
Okhla Industrial Estate, New Delhi - 110020 |
|
|
Primary Sponsor
|
| Name |
National Biopharma Mission, Biotechnology Industry Research Assistance Council (BIRAC) |
| Address |
NSIC Estate, Okhla Phase III, Okhla Industrial Estate, New Delhi, Delhi 110020 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhidnya V Desai |
Tata Memorial Hospital |
Institutional Review Board Dept, Main Building 372, Dr E Borges, Marg Parel 400012 Mumbai India
Mumbai
MAHARASHTRA |
9833348059
avdesai06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audio-video ICF application |
Audio-video ICF application for 2 years |
| Comparator Agent |
written ICF |
written ICF for 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adults (18+) who are potential research participants, who have the capacity to provide informed consent, and who are not impaired by any cognitive disabilities that would hinder
comprehension. |
|
| ExclusionCriteria |
| Details |
Individuals with auditory or visual impairments that make it difficult to use the
audio-visual tool or read the written document. Participants who have prior participation in clinical
tria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
1) To develop and pilot test an audio-visual tool providing information about the research study for ongoing research studies with varying degree of complexity or risk to the participants.
2) To evaluate incremental benefit of audio-visual tool in combination with written Informed Consent Document on comprehension of the research participants.
|
1-2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome-
1) To assess the additional time commitment of the research participants with the use of the audio-visual tool.
2) To evaluate cost-effectiveness of the audio-visual tool |
3rd year |
|
|
Target Sample Size
|
Total Sample Size="222"
Sample Size from India="222"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We aim to assess whether adding an audio-visual tool makes the informed consent process clearer and more effective for participants compared to using only a written document. 1.Develop and test an audio-visual tool that explains research studies in an engaging and accessible way. 2.Compare how well participants understand study details when using both the audio-visual tool and the written document versus the written document alone with the help of a questionnaire developed by the study team to evaluate the comprehensiveness of Informed consent form and Audio-Visual consent tool.
|